FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
127897–127920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1989
HEMA-PRIMER
K895750 · KLE
Parkell
Dental · 86d
Cleared Dec 21, 1989
LATEX PATIENT EXAMINATION GLOVES
K895754 · LYY
Frontline Latex Products Pvt. , Ltd.
General Hospital · 84d
Cleared Dec 21, 1989
SILCOT COPAL CAVITY VARNISH
K895798 · EMA
Specialites Septodont
Dental · 84d
Cleared Dec 21, 1989
MODEL 4070 TEMPERATURE MONITOR
K895875 · FLL
Mallinckrodt Anesthesia Products
General Hospital · 78d
Cleared Dec 21, 1989
PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR
K896167 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 57d
Cleared Dec 21, 1989
MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN
K896485 · GXY
Empi
Neurology · 38d
Cleared Dec 21, 1989
GYROVIEW HR HIGH RESOLUTION WORKSTATION
K896647 · LNH
Philips Medical Systems North...
Radiology · 27d
Cleared Dec 20, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892194 · LYY
Pao Chen Industrial Co., Ltd.
General Hospital · 253d
Cleared Dec 20, 1989
SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL)
K893800 · EJT
Deringer-Ney, Inc.
Dental · 212d
Cleared Dec 20, 1989
BIOCHEM 3100 OXIMETER
K893877 · DQO
Biochem International, Inc.
Cardiovascular · 208d
Cleared Dec 20, 1989
TALLADIUM TILITE CERAMIC ALLOY
K894085 · EJH
Talladium, Inc.
Dental · 195d
Cleared Dec 20, 1989
NKA MODEL SEC-3102 CARDIAC STIMULATOR
K894492 · DRO
Nihon Kohden America, Inc.
Cardiovascular · 155d
Cleared Dec 20, 1989
LATEX PATIENT EXAMINATION GLOVES
K894900 · LYY
Fujian Ming Sheng Chemistry
General Hospital · 141d
Cleared Dec 20, 1989
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
K895447 · DTB
Pacesetter Systems
Cardiovascular · 103d
Cleared Dec 20, 1989
PLASTIC TOOTH REINFORCEMENT KIT
K895758 · EBL
Nanzee Dental Products
Dental · 85d
Cleared Dec 20, 1989
INFLATION PRO II
K895836 · MAV
Baxter Healthcare Corp
Cardiovascular · 78d
Cleared Dec 20, 1989
REVISED PATIENT EXAMINATION GLOVES
K896411 · LYY
Pt. Trihasta Loka Persada
General Hospital · 42d
Cleared Dec 20, 1989
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS
K896443 · DTB
Possis Medical, Inc.
Cardiovascular · 41d
Cleared Dec 20, 1989
TOYOSUYA LATEX EXAMINATION GLOVES
K896489 · LYY
Toyosuya Sdn Bhd
General Hospital · 37d
Cleared Dec 19, 1989
LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II
K891691 · DIE
Bio-Rad
Toxicology · 272d
Cleared Dec 19, 1989
SYS*STIM 206A
K893878 · IPF
Mettler Electronics Corp.
Physical Medicine · 207d
Cleared Dec 19, 1989
SYS*STIM 207A
K893879 · IPF
Mettler Electronics Corp.
Physical Medicine · 207d
Cleared Dec 19, 1989
SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY
K894175 · JHI
Serono-Baker Diagnostics, Inc.
Chemistry · 187d
Cleared Dec 19, 1989
.650 FINE GOLD SOLDER
K895054 · EJT
Leach and Dillon Co., Inc.
Dental · 133d